Do you print 24×7 from MES or Track-and-Trace systems? We show you what pharma serialization means for label printing on packaging systems.
Serialization in the pharmaceutical industry
Pharmaceutical companies rely on serialization to prevent product piracy on medicines and the associated increase in patient safety. The EU Falsified Medicines Directive 2011/62/EU makes this mandatory for prescription medicines. The health authorities of the EU countries, but also the directives of other countries, aim to make medicines counterfeit-proof. They therefore require that medicinal products are clearly identifiable and therefore traceable.
Labeling as a success factor
The GS1 standard plays an important role in pharmaceutical serialization. The standard is used to encode the unique product identification, e.g. a serial number, in a standardized form (SGTIN). This not only ensures that you comply with the law, but also that this information is recorded securely and quickly along the supply chain.
Labeling on packaging systems poses a particular challenge. Inline printing is therefore a central and critical system for your production.
Firstly, the clock rates are very high and secondly, they usually run around the clock(7×24). This means that online printing directly from SAP is often not performant enough. Interfaces to track-and-trace, which take over the verification of the coding, are therefore indispensable.
Requirements for labels in the pharmaceutical industry
Labels on primary and secondary packaging and pallets must fulfill many requirements from the perspective of a pharmaceutical company. In addition to the legal requirements for unique and individual identification, they also take into account production-related and logistical requirements. The most important requirements of our pharmaceutical customers with regard to labelling, serialization and aggregation of packaging are:
What product identifications need to be coded?
All country guidelines require an individual product identification number, the expiry date of a medicine and a batch number or, if applicable, a serial number. The format of these labels varies from country to country.
The product identification number typically contains the country prefix, the company number, the article number and a check digit. However, what all directives require in equal measure is human-readable plain text and machine-readable barcodes.
Experience inline printing for serialization live?
We would be happy to show you the possibilities in a live demo or carry out a test installation on your system together with you.
The top 6 challenges in pharmaceutical labeling
Based on the experiences of our pharmaceutical customers as well as the requirements for labeling systems, we have put together the 6 most important challenges for labeling in the pharmaceutical industry.
Barcode symbologies and standards
The use of barcodes is very important for correct coding in pharmaceutical serialization and aggregation at packaging levels. You must be able to use different barcode types (Code 128, Datamatrix, QR code), depending on the requirements of the target markets and products. They create the barcodes on the labels in a standardized form, for example the GS1 standard.
Verification using machine-readable text
Verification is necessary so that you can check whether the legally required product information has been printed correctly. Verification is typically performed individually at each aggregation level. In doing so, you use a machine-readable font, such as OCR, to facilitate optical verification by the Track-and-Trace system.
Symbols according to ISO standard
For serialization and aggregation in the pharmaceutical industry, product information is often visually marked with symbols. You can use ISO symbols in the label design, for example for an expiration date, a batch number or a temperature range. These help your international customers to read the product information on the packaging.
Label versions and releases
Pharmaceutical companies are highly regulated businesses, so it is imperative that you version labels and establish a controlled approval process. Flexible approval workflows with electronic signatures are just as important as corresponding audit trails to meet the requirements of GxP environments.
Offline printing on the line
With a 2-stage printing process, you can supply your labels to the production and packaging systems on an order-specific basis. At the time of production, your track-and-trace systems enrich the labels with real-time data and print them on the line according to the cycle time. This allows you to achieve independent production systems that run 24/7 without a connection to the ERP.
Real-time data from production facilities
In pharma serialization, production data often only emerges at the time of manufacture. Information such as the production and expiry date, the batch number, a serial number or the packaged quantities must therefore be transferred to the label printer in real time. Your MES systems or Track-and-Trace systems are therefore provided with an interface for high-performance product labeling.
A serialization specialist talks about his experiences
Philipp Glockner
Business Solutions Architect
Illegal or incorrectly marked retail units are immediately recognized by the cameras integrated into the track-and-trace system and automatically sorted out. However, not without marking the corresponding serial number as invalid in the database. The physical machine level had to be networked with the package line software so that both operating statuses and data could be checked at any time.
Communication between the track-and-trace system, OPAL LABELMANAGEMENT™, the machine control system and the monitoring system was a new challenge for us.
SAP Track and Trace
As the successor to SAP AII (SAP Auto-ID Infrastructure) as well as SAP OER (SAP Object Event Repository), they are now using SAP ATTP (SAP Advanced Track and Trace for Pharmaceuticals) for serialization in the pharmaceuticals area. With ATTP, you can ensure compliance with international and regional legislation.
The SAP ATTP, based on the EPC Information Services (EPCIS) standard, serves as the central serialization repository. The focus here is on the assignment and management of serial numbers as well as reporting functions.
At the packaging system level (Level 2), a Track-and-Trace system is used to ensure the utilization and verification of the coding. In pharmaceutical serialization, the use of a serial number is the key element. Label printing in packaging systems must therefore be integrated into production control and the Track-and-Trace system. With the Line Print Agent (LPA), we have successfully integrated the leading manufacturers of Track-and-Trace systems and print labels directly (inline) into the packaging process.
Customers from the pharmaceutical industry
Would you like to see live how we serialize labels?
Book a personal live demo with our experts. We will show you how easy it is to manage labels centrally in SAP and print them with track and trace systems in the packaging line.
Labeling in pharmaceutical serialization
